CTRI Number |
CTRI/2022/06/043369 [Registered on: 20/06/2022] Trial Registered Prospectively |
Last Modified On: |
20/06/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Evaluation of safety and tolerability of HASG-072009 Capsules in healthy people |
Scientific Title of Study
|
“An Open-Label, Single-Arm Clinical Study to evaluate the Safety and Tolerability of HASG-072009 Capsules in Healthy Adults". |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Dinesh S |
Designation |
Consultant pulmonologist |
Affiliation |
Xplora Clinical Research Services Pvt.Ltd |
Address |
Xplora Clinical Research Pvt Ltd, Room No.01,Division Clinical
Research, Door No. 252, 13th Cross, Wilson Garden,
Bangalore.
Bangalore KARNATAKA 560027 India |
Phone |
9886125229 |
Fax |
|
Email |
bhaktha.dinesh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Srikrishna |
Designation |
Research Scientist |
Affiliation |
Himalaya Wellness Company |
Address |
302, 3rd floor, clinical pharmacology, R and D, Makali,
Bangalore Rural
Bangalore KARNATAKA 562162 India |
Phone |
08067547230 |
Fax |
|
Email |
dr.srikrishna@himalayawellness.com |
|
Details of Contact Person Public Query
|
Name |
Kavitha R |
Designation |
Senior Research Associate |
Affiliation |
Himalaya Wellness Company |
Address |
302, 3rd floor, clinical pharmacology, R and D, Makali,
Bangalore Rural
Bangalore KARNATAKA 562162 India |
Phone |
08067547231 |
Fax |
|
Email |
kavitha.rangaiah@himalayawellness.com |
|
Source of Monetary or Material Support
|
Himalaya Wellness Company |
|
Primary Sponsor
|
Name |
Himalaya Wellness Company |
Address |
Tumkur road, Makali, banglore Bangalore Rural |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrDinesh |
Xplora Clinical Research services |
No. 252, 13th Cross, Wilson Garden,
Bangalore – 560027
Bangalore KARNATAKA |
9886125229
bhaktha.dinesh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ACE indepedent Ethics commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy adult volunteers |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: HASG-072009, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 345(mg), Frequency: od, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Healthy adult subjects of either sex aged between ≥ 18 to ≤ 50 years.
2. Subjects willing to sign informed consent and follow the study procedure.
3. Has not participated in a similar investigation in the past four weeks.
4. Subjects willing to refrain taking any other similar supplements during the study period
|
|
ExclusionCriteria |
Details |
1.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, hepatic, renal disease, congenital or any other disorder.
2.Subject with abnormal lab values detected at the time of screening shall be excluded.
3.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational product.
4.Pre-existing systemic disease necessitating long-term medications.
5.Genetic and endocrinal disorders.
6.Subjects who refused to sign informed consent.
7.Pregnant and lactating women.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Occurrence of any adverse or serious adverse
events during the study period. |
7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
overall compliance of study medication |
7 days |
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/06/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In an era of stress driven daily living activities carried out by schoolers to the working, elderly, and retired individuals; a healthy, calm and enjoying way of carrying out and making to carry out the daily living activities have been completely compromised with enhanced self-deceitful, suspicious approach towards individual self and human connections. This in turn has led and is still leading every individual to completely succumb to the global systemic impact of physical, emotional, intellectual stress thereby altering the normal physiological overall growth response and progressive pathological response to the stressful stimuli and thereby reduce your focusing ability In addition to the above, the foremost etiology for this stress driven activities could be attributed to the fast-track mode of daily living in terms of diet and lifestyle. This indeed has accelerated the progression of various underlying pathological processes and thereby leading every human to succumb for various psychosomatic disorders. As a ground-breaking reality, adhering to the ancient principles and practices of healthy dietary and lifestyle guidelines seems to be the only conscious driven therapeutic measures to combat the detrimental impact. In an attempt of incorporating the same and keeping the global systemic impact of stress and the acquired a focused mind to carry out the normal daily living activities, a novel polyherbal formulation HASG-072009 has been formulated to combat the global systemic visceral impact and bring about a focused state of mind in carrying out every daily living activities. This study is planned to evaluate the safety and tolerability of the novel formulation in healthy adult individuals. |